MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TELIGEN; IMPLANTABLE DEFIBRILLATOR

Model Number E110

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 11/01/2022

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was explanted due to exhibiting noise, oversensing and high out of range pacing impedance measurements.It was determined that this was due to the right ventricular lead experiencing fracture, furthermore, due to this, the device delivered inappropriately a shock to the patient.Another device was implanted instead.No further adverse patient effects were reported.

• Brand Name: TELIGEN
• Type of Device: IMPLANTABLE DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15847460
• MDR Text Key: 304169765
• Report Number: 2124215-2022-48623
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/21/2012
• Device Model Number: E110
• Device Catalogue Number: E110
• Device Lot Number: 174753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male